FDA requests additional safety data of Dynavax’s hep B vaccine

The US FDA has asked Dynavax Technologies Corporation for additional safety data on its investigational adult hepatitis B vaccine, Heplisav. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

The regulatory body denied approval for Heplisav back in February saying that the data provided was insufficient. Dynavax will now facilitate an additional review of the vaccine in adults 18-70 years old.

“We are encouraged by the supportive feedback received from the FDA and appreciate the informative interactions and clarity provided regarding HEPLISAV’s path toward approval in the broader indication. We understand the rationale for the Agency’s recommendations and will give full consideration to their feasibility and timing as we advance HEPLISAV’s development.”
 
Eddie Gray, Dynavax’s Chief Executive Officer.

 

Dynavax has said it will meet with the FDA to discuss the protocol for collecting the additional safety data, which is expected to be incorporated into the existing Biologics License Agreement (BLA). The company will also continue to work on the questions raised by the FDA, regarding the manufacturing and testing of Heplisav and will provide updates as appropriate.

In 2009, the overall incidence of reported acute hepatitis B was 1.5 per 100,000 people. However, because many hepatitis b infections are never reported, the actual number of new infections is estimated to be approximately tenfold higher, according to the Centers for Disease Control and Prevention (CDC).

 

Related news:

UPDATE 1-Dynavax’s hep B vaccine delayed as FDA seeks more data (Reuters)

Dynavax Falls as FDA Seeks Broader Study of Vaccine (Bloomberg)

Reference links:

Dynavax press release

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